Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

Last updated: April 9, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Terminated

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Valganciclovir

Clinical Study ID

NCT04064697
18PH192
2019-001032-54
  • Ages > 18
  • All Genders

Study Summary

Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo.

CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC).

Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p<0.05).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo scoregreater than 5
  • Patient with an inflammatory outbreak of Ulcerative Colitis (UC) :
  • without anti-TNF
  • under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primaryresponse) or clinical recurrence (secondary failure).
  • Having rectosigmoidoscopy with an endoscopic Mayo score≥ 2 with 2 biopsies of theinflammatory tissue
  • Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral loadgreater than 5 IU / 100000 cells by qPCR)
  • Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCVserology, a negative quantiferon or a history of tuberculosis preventive treatmentadapted by Rifinah or Rimifon
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Patient with severe acute colitis
  • Patient treated by ciclosporin or Prograf
  • Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C,tuberculosis
  • Clostridium difficile infection.
  • Patient with intolerance or contraindications to current therapy
  • Pregnant or starts breastfeeding
  • Patient who received a live vaccine in the month preceding the study
  • Patients with severe renal insufficiency defined by creatinine clearance <30ml/minute,or hemodialysed

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Valganciclovir
Phase: 3
Study Start date:
April 22, 2021
Estimated Completion Date:
February 08, 2024

Study Description

The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation ; not responding to anti-TNF or without anti-TNF ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.

Connect with a study center

  • CH d'Annecy

    Annecy,
    France

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU de Lyon Sud

    Lyon,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • CHU de Nice

    Nice,
    France

    Site Not Available

  • APHP - Hôpital Saint-Antoine

    Paris,
    France

    Site Not Available

  • CHU ROUEN - Service Gastro-entérologie

    Rouen,
    France

    Site Not Available

  • CHU de Saint Etienne

    Saint-Étienne,
    France

    Site Not Available

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